[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100649839":3},{"organization":4,"armGroups":7,"interventions":27,"overallOfficials":34,"centralContacts":38,"locations":44,"responsibleParty":101,"collaborators":33,"id":103,"slug":104,"hasResults":105,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":33,"eligibilityCriteria":109,"healthyVolunteers":105,"sex":110,"minAge":111,"maxAge":33,"enrollmentInfo":112,"targetDuration":33,"studyType":115,"phases":116,"briefSummary":118,"conditions":119,"keywords":128,"overallStatus":133,"whyStopped":33,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":135,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":143},{"fullName":5,"class":6},"Iksuda Therapeutics Ltd.","INDUSTRY",[8,14,18,21,24],{"label":9,"type":10,"description":11,"interventionNames":12},"Dose Escalation Cohort (Part I)","EXPERIMENTAL","Each patient will receive repeat doses by IV infusions on Day 1 of each 21-day cycle.",[13],"Drug: IKS04 antibody drug conjugate ADC + Isumab04 monoclonal antibody",{"label":15,"type":10,"description":16,"interventionNames":17},"Dose Expansion (Part II): CA242+ Colorectal Cancer Participants","The IKS04 Regimen will be administered IV at the RP2D or RDE identified in Part I on Day 1 of each 21-day cycle.",[13],{"label":19,"type":10,"description":16,"interventionNames":20},"Dose Expansion (Part II): CA242+ Gastro-Esophageal Adenocarcinoma Participants",[13],{"label":22,"type":10,"description":16,"interventionNames":23},"Dose Expansion (Part II): CA242+ Biliary Tract Cancer Participants",[13],{"label":25,"type":10,"description":16,"interventionNames":26},"Dose Expansion (Part II): CA242+ Advanced Solid Tumor Cancer Participants",[13],[28],{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"DRUG","IKS04 antibody drug conjugate ADC + Isumab04 monoclonal antibody","IKS04 Regimen \\[Isumab04 (the antibody component of IKS04) followed by IKS04 ADC\\]",[9,25,22,15,19],null,[35],{"name":36,"affiliation":5,"role":37},"James O'Leary, MD","STUDY_DIRECTOR",[39],{"name":40,"role":41,"phone":42,"phoneExt":33,"email":43},"David Browning","CONTACT","+615-975-7776","david.browning@iksuda.com",[45,62,75,88],{"facility":46,"status":33,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"UCLA Medical Center","Los Angeles","California","90404","United States","US",{"type":53,"coordinates":54},"Point",[55,56],-118.24368,34.05223,{"lat":56,"lon":55},[59],{"name":60,"role":61,"phone":33,"phoneExt":33,"email":33},"Randy Hecht, MD","PRINCIPAL_INVESTIGATOR",{"facility":63,"status":33,"city":64,"state":65,"zip":66,"country":50,"countryCode":51,"cosmosGeoPoint":67,"geoPoint":71,"contacts":72},"Mass General Hospital","Boston","Massachusetts","02114",{"type":53,"coordinates":68},[69,70],-71.05977,42.35843,{"lat":70,"lon":69},[73],{"name":74,"role":61,"phone":33,"phoneExt":33,"email":33},"Leon Pappas, MD",{"facility":76,"status":33,"city":77,"state":78,"zip":79,"country":50,"countryCode":51,"cosmosGeoPoint":80,"geoPoint":84,"contacts":85},"Vanderbilt University Medical Center","Nashville","Tennessee","37232",{"type":53,"coordinates":81},[82,83],-86.78444,36.16589,{"lat":83,"lon":82},[86],{"name":87,"role":61,"phone":33,"phoneExt":33,"email":33},"Jordan Berlin, MD",{"facility":89,"status":33,"city":90,"state":91,"zip":92,"country":50,"countryCode":51,"cosmosGeoPoint":93,"geoPoint":97,"contacts":98},"MD Anderson Cancer Center","Houston","Texas","77030",{"type":53,"coordinates":94},[95,96],-95.36327,29.76328,{"lat":96,"lon":95},[99],{"name":100,"role":61,"phone":33,"phoneExt":33,"email":33},"Kanwal Raghav, MD",{"type":102,"investigatorFullName":33,"investigatorTitle":33,"investigatorAffiliation":33,"oldNameTitle":33,"oldOrganization":33},"SPONSOR","100649839","phase-1-iks04-regimen-in-advanced-solid-tumors-that-express-ca242-100649839",false,"NCT07738939","IKS04 Regimen in Advanced Solid Tumors That Express CA242","A Phase 1 Dose Escalation Trial to Determine the Safety, Tolerance, Maximum Tolerated Dose, and Preliminary Antineoplastic Activity of the IKS04 Regimen Targeting CA242","Key Inclusion Criteria:\n\n* Advanced or metastatic CRC, BTCs, GEA, and PDAC that is histologically or cytologically confirmed\n* Disease that has progressed despite prior treatment, for which additional effective therapy is not available, not tolerable, is contraindicated, or the participant refuses standard therapy.\n* Platelets ≥ 100,000 \u002FmcL\n* Hemoglobin ≥ 9.0 g\u002FdL., no transfusions with RBCs are allowed within 2 weeks prior to first trial drug administration\n* ANC ≥ 1500\u002FmcL\n* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \\[SGOT\\])\u002Falanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \\[SGPT\\]) ≤ 3 x institutional upper limit of normal (ULN) ≤ 5 x ULN if liver metastases present\n* Total bilirubin ≤ 1.5 x ULN, unless participant has Gilbert's Syndrome\n* Albumin \\> 2.5 g\u002FdL\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1\n\nPart I\n\n* Fresh biopsy tissue or formalin-fixed paraffin-embedded (FFPE) tumor tissue block or slides available for retrospective assessment of CA242 positivity in a central laboratory.\n* Measurable and non-measurable disease\n\nPart II\n\n* Fresh biopsy tissue or FFPE tumor tissue block or slides for assessment of CA242 positivity in a central laboratory prior to administration of first dose of study drug.\n* Measurable disease only\n\nKey Exclusion Criteria:\n\n* Participants with a significant pulmonary disease or condition, including:\n\n  * Significant symptomatic chronic obstructive pulmonary disease (COPD), as assessed by the Investigator.\n  * History or any current evidence on imaging studies of interstitial lung disease (ILD), pulmonary fibrosis.\n  * History of pulmonary inflammatory disease, pneumonitis, acute respiratory distress syndrome (ARDS).\n  * History of pneumonia within 3 months prior to the first trial drug administration.\n* Participants who have received previous treatment with any CA242 directed ADC or any ADC containing a PBD payload for their current tumor indication.\n* Participant may not have received more than 5 prior lines of systemic therapy.\n* Received treatment with a strong cytochrome P450 (CYP) 3A4 inhibitor within 7 days or 5 half-lives (whichever is longer) prior to the first trial drug administration\n* Central nervous system metastatic disease unless treated prior to first dose of trial drug.\n* Active second malignancy or history of another malignancy within the last 2 years with specific exceptions as per protocol\n* Active, known or suspected autoimmune disease, or a documented history of autoimmune disease or syndrome requiring systemic steroids or other immunosuppressive medications, such as:\n\n  * Myocarditis, pneumonitis, glomerulonephritis.\n  * Autoimmune hepatitis, inflammatory bowel disease (IBD)\n  * Sjogren's syndrome\n  * Rheumatoid arthritis (RA), systemic lupus erythematosus (SLE)\n  * Myositis\n  * Myasthenia gravis\n  * Guillain-Barré Syndrome\n  * Multiple sclerosis\n  * Granulomatosis with polyangiitis (Wegner's granulomatosis)\n  * Vasculitis","ALL","18 Years",{"count":113,"type":114},120,"ESTIMATED","INTERVENTIONAL",[117],"PHASE1","This study will evaluate the safety, tolerability, anti-tumor activity, immunogenicity, pharmacokinetics and pharmacodynamics of the IKS04 Regimen and identify a recommended phase 2 dose (RP2D) or recommended dose for further evaluation in expansion (RDE). The regimen includes Isumab04 (unconjugated antibody) followed by the IKS04 antibody-drug conjugate, both directed against the CA242 (CanAg) tumor-associated antigen and administered intravenously (IV) in patients with advanced solid cancers.",[120,121,122,123,124,125,126,127],"Colorectal Cancer","Gastro Esophageal Junctional Cancer","Gastric Cancer (GC)","GEJ Adenocarcinoma","PDAC - Pancreatic Ductal Adenocarcinoma","Biliary Tract Cancer (BTC)","Gall Bladder Cancer","Cholangiocarcinoma",[129,130,131,132],"CA242","advanced gastrointestinal tumors","IKS04","Isumab04","NOT_YET_RECRUITING","2026-07-27",{"date":136,"type":137},"2026-07-31","ACTUAL",{"date":139,"type":114},"2026-11",{"date":141,"type":114},"2029-12",{"name":5,"class":6},4]